Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
44
Countries
2
Sites
3
Glioblastoma
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Nov 2023 → 1 Aug 2025
- Decision date (initial)
- 2023-11-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506409-20-00
- WHO UTN
- U1111-1295-0666
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glioblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 4 | 1 |
| Spain | Ended | 10 | 2 |
| Rest of world
United States
|
— | 30 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-12-14 | 2025-06-04 | 2024-06-26 | 2024-11-26 | |
| Spain | 2023-11-24 | 2025-07-31 | 2024-03-11 | 2024-11-26 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-26 | Spain | Acceptable 2023-11-06
|
2023-11-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-15 | Spain | Acceptable 2024-03-11
|
2024-03-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-07 | Spain | Acceptable 2024-07-16
|
2024-07-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-10 | Spain | Acceptable 2024-07-16
|
2024-12-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-27 | Spain | Acceptable 2025-05-21
|
2025-05-21 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-25 | Spain | Acceptable 2025-05-21
|
2025-07-25 |